COPD excerbation salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

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StudyEvent: ODM
1. COPD excerbation salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

COPD EXACERBATIONS

Descripción

COPD EXACERBATIONS

Alias

UMLS CUI-1: C0740304

Was there a COPD exacerbation?

Descripción

COPD exacerbation

Tipo de datos

text

Alias

UMLS CUI [1]: C0740304

Yes (Y)

No (N)

If "yes" to COPD exacerbation, record following items.

Descripción

If "yes" to COPD exacerbation, record following items.

Alias

UMLS CUI-1: C0740304

Date of Onset

Descripción

date of onset of COPD exacerbation

Tipo de datos

date

Alias

UMLS CUI [1,1]: C0574845

UMLS CUI [1,2]: C0740304

Outcome

Descripción

outcome of COPD exacerbation

Tipo de datos

integer

Alias

UMLS CUI [1,1]: C0085565

UMLS CUI [1,2]: C0740304

Resolved (1)

Fatal (2)

Not resolved (3)

Date of Resolution or Death

Descripción

date of resolution or death

Tipo de datos

date

Alias

UMLS CUI [1]: C2985858

UMLS CUI [2]: C1148348

Severity

Descripción

severity of COPD excerbation

Tipo de datos

integer

Alias

UMLS CUI [1,1]: C0439793

UMLS CUI [1,2]: C0740304

moderate (2)

severe (3)

Was the subject withdrawn due to this exacerbation?

Descripción

Subjects who experience more than one moderate exacerbation requiring antibiotic and/or oral corticosteroid treatment during the treatment period and/or experience a severe exacerbation requiring hospitalisation during the course of the study must be withdrawn.